A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment

• ClinicalTrials.gov Identifier: NCT05597085
• Recruitment Status: Not yet recruiting
• First Posted: October 27, 2022
• Last Update Posted: November 7, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: October 24, 2022
• First Posted Date: October 27, 2022
• Last Update Posted Date: November 7, 2022
• Estimated Study Start Date: November 2022
• Estimated Primary Completion Date: February 15, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 24, 2022)

• Percentage of participants who have achieved complete remission or complete remission with incomplete haematological recovery following treatment with InO in 1st salvage [ Time Frame: From last dose of InO; up to 6 months ]
• Percentage of participants who have achieved complete remission or complete remission with incomplete haematological recovery following treatment with InO in 2nd salvage [ Time Frame: From last dose of InO; up to 6 months ]
• Percentage of participants who have achieved complete remission or complete remission with incomplete haematological recovery following treatment with InO in 3rd salvage [ Time Frame: From last dose of InO; up to 6 months ]
• Percentage of participants who have achieved complete remission or complete remission with incomplete haematological recovery following treatment with InO in >3 lines of salvage [ Time Frame: From last dose of InO; up to 6 months ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 24, 2022)

• Percentage of participants achieving Minimum Residual Disease (MRD) Negativity in participants achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) [ Time Frame: Up to approximately 6 months from last dose of InO ]
  MRD analysis performed in participants who achieved CR or CRi. Bone marrow aspirates, collected and sent to laboratory and analyzed using multiparametric flow cytometry
• Number of cycles of InO needed to attain CR/CRi determined by laboratory testing [ Time Frame: Up to 6 months after the last dose of InO ]
• Duration of Remission (DoR) for participants who achieved CR/CRi (per investigator assessment). [ Time Frame: Up to 6 months after the last dose of InO ]
  DoR was defined as time from date of first response in responders (CR/CRi per investigator assessment) to date of PFS event (i.e. death, progressive disease [objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status] or starting new induction therapy or post-therapy stem cell transplant [SCT] without achieving CR/CRi).
• Number of participants categorized according to dose modifications [ Time Frame: Up to 6 months after the last dose of InO ]
• Number of participants categorized according to number of cycles [ Time Frame: Up to 6 months from last dose of InO ]
• Number of participants with concomitant medications [ Time Frame: Upto 6 months after last dose of InO ]
• Hematopoietic stem cell transplantation (HSCT) rate was defined as the percentage of participants who underwent stem cell transplantation (SCT) following treatment with InO [ Time Frame: Up to 6 months from last dose ]
  Number of patients who proceed to transplant
• Overall survival (OS) in transplanted participants [ Time Frame: At 6 months and 1 year after the last dose of InO ]
  OS is defined as the time from start of therapy to date of death due to any cause.
• Overall survival (OS) in non transplanted participants [ Time Frame: At 6 months & 1 year after the last dose of InO ]
  OS is defined as the time from start of therapy to date of death due to any cause.
• Number of participants categorized according to cause of death [ Time Frame: At 6 months & 1 year after the last dose of InO ]
• Relapse-free-survival in months determined by progression of disease and flowcytometric evaluation (all participants) [ Time Frame: From last dose of InO; up to 6 months & 12 months ]
• Relapse free survival in months determined by progression of disease and flowcytometric evaluation (participants with follow up HSCT) [ Time Frame: Up to 6 months & 1 year after last dose of InO ]
• Relapse free survival in months determined by progression of disease and flowcytometric evaluation (participants without follow up HSCT) [ Time Frame: From last dose of InO; up to 6 months & 12 months ]
• Rate of Hepatic veno-occlusive disease (VOD) in transplanted participants determined by Liver function tests [ Time Frame: Up to 1 year from last dose of InO ]
  VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules.
• Rate of Hepatic veno-occlusive disease (VOD) in non-transplanted participants determined by Liver function tests [ Time Frame: Up to 1 year from last dose of InO ]
  VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules.
• Number of participants reporting Grade 3/4 treatment related Adverse Events following InO initiation [ Time Frame: Up to 1 year from last dose of InO ]
  Grades 3 are severe and undesirable adverse events and grade 4 are life threatening or disabling adverse events
• Percentage of participants who achieved complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) in extramedullary disease and Lymphoblastic Lymphoma (LBL) [ Time Frame: Up to 1 year from last dose of InO ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment
• Official Title: A Retrospective Analysis of Inotuzumab Ozogamicin Usage in Adult Patients With Relapsed/Refractory (R/R) B-cell Acute Lymphoblastic Leukemia (ALL)

Brief Summary

The purpose of the study was to understand the effectiveness and safety of the study medicine called Inotuzumab ozogamicin (InO) in patients with B-cell ALL in whom the disease occurred again after the last treatment.

This retrospective Study enroll adult patients who:

• were CD22 positive (a molecule in the body that stops the over activity of the immune system)
• Received only InO for the treatment of B-cell ALL that occurred again after the last treatment
• were Philadelphia chromosome positive (which occurs because of changes in genes)
• failed treatment with at least one Tyrosine Kinase Inhibitor (type of medicine that blocks the action of enzymes called tyrosine kinases which takes care of many cell functions, such as cell growth and division).

The patient data except their personal details are collected from a hospital based electronic medical record in India.

In this study the effectiveness and safety of InO will be studied after it was released to the market.

To do that, the study aims to gather details of B-cell ALL patients from 7 -10 hospitals across India:

• in whom the disease occurred again
• or those who never showed any improvement to earlier treatments
• now being treated with InO alone

Around 55 patients who have taken InO are likely to be enrolled in the study.

Then by using a statistical model and with all the information gathered, the safety and effectiveness of InO will be decided.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Adult Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia Patients
• Condition: Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia

Intervention

Drug: Inotuzumab Ozogamicin

Inotuzumab Ozogamicin is an Antibody drug conjugate directed against CD 22 positive B Cell ALL

Other Names:

• Besponsa
• Inonza

Study Groups/Cohorts

Adult relapsed or refractory B Cell ALL

Adult patients whose B Cell ALL has occurred again after the last treatment or patients who never responded to prior treatment

Intervention: Drug: Inotuzumab Ozogamicin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 24, 2022): 55
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 15, 2023
• Estimated Primary Completion Date: February 15, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients aged ≥18 years old at the initiation of InO treatment

  • Patients with relapsed/refractory B-cell ALL
  • Patients who initiated InO monotherapy between Feb'2017 and Feb'2022 and are CD22 positive
  • Ph+ patients who have failed treatment with at least 1 TKI

Exclusion Criteria:

• Patient not completing at least 1 cycle of InO therapy • Patient on InO in combination with chemotherapy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05597085
• Other Study ID Numbers: B1931043
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: November 2022